By Joseph Harvey
January 31, 2017
Jaguar Animal Health has struck an agreement with Elanco to bring Canalevia through to commercialization.
The deal will see the two firms license, develop and commercialize Canalevia – a Jaguar drug candidate being developed for the treatment of acute and chemotherapy-induced diarrhea (CID) in dogs. Crofelemer is Canalevia's active ingredient, a botanical extract derived from the Croton lechleri tree which is also the active ingredient in many of Jaguar's other product candidates.
Last year, Jaguar revealed final topline results for a multicenter proof-of-concept study of the active ingredient in Canalevia.
The San Francisco-based business is currently undertaking a final pivotal field study to evaluate the safety and efficacy of Canalevia for treatment of acute diarrhea in dogs. Approximately 200 dogs were enrolled in the pivotal study at the end of 2016.
The agreement gives Elanco exclusive global rights to Canalevia. Jaguar and Elanco will collaborate on the global development of the product and on its commercialization in the US.
Jaguar will receive an upfront payment of $1.5 million, as well as additional payments upon the achievement of certain development, regulatory and sales milestones in an aggregate amount of up to $61 million. This amount will be payable throughout the term of the agreement. Jaguar will also receive product development expense reimbursement and royalty payments on global sales of Canalevia.
Elanco will also reimburse Jaguar for Canalevia-related expenses incurred in the fourth quarter of 2016, certain expenses related to the planned target animal safety study and the completion of a field study of Canalevia for acute diarrhea in dogs.
The partnership states Jaguar will supply the licensed products to Elanco, after which "the parties will agree to set a minimum sales requirement that Elanco must meet to maintain exclusivity".
The firm said: "Jaguar has retained the commercial responsibility for the CID indication of Canalevia in dogs, which has received MUMS designation from the FDA and which the company expects will be the first indication available commercially in the next year.
"Jaguar has established a foundation of direct educational and promotional capabilities for novel anti-secretory agents through its non-prescription product line for production animals."
Boon for Jaguar
Not only could this deal provide Jaguar with significant income but it may also provide a boost to the company's languishing share price. Jaguar's share price has been below $1 for over two months.
Lisa Conte, Jaguar's president and chief executive, said: "We believe this agreement will significantly expand market awareness regarding the novel, anti-secretory mechanism of action of crofelemer and its potential to serve as a new method of treating diarrheal diseases. We anticipate that commercialization of Canalevia will expand our range of first-in-class gastrointestinal products beyond production animals, horses and foals to companion animals in need around the world, and we believe that the collaboration with Elanco will provide broad access to key markets globally."
Previously, Ms Conte told Animal Pharm about the disparity between the firm's languishing share price and its R&D achievements.
Elanco's increasing pet focus
The deal with Jaguar is another sign of Elanco's strategy of partnering for the commercialization of new companion animal products.
Last week, the company made Galliprant available to US dogs after a landmark deal with Aratana Therapeutics.
This is just one example of how Elanco has been ramping up its companion animal product portfolio. The firm has also acquired pet vaccine assets from Boehringer Ingelheim, while it has also been developing the acquired pipeline of Novartis Animal Health. Over the past 18 months, it has been introducing many products and indications that were previously being formulated in Novartis' pipeline such as Osurnia, a two-dose treatment for canine otitis externa, and onsior, for the control of post-operative pain and inflammation associated with soft tissue surgery in dogs. Reprinted with permission of Animal Pharm News